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Completed

NCT Number: NCT05501600

Neural Correlates of Lidocaine Analgesia

The purpose of this study is to characterize the effects of intravenous lidocaine on pain processing and cognitive function. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will consist of 1 visit and involves no long-term follow up.

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Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

This is an observational cohort study of volunteer subjects, which will employ neuroimaging and behavioral measures to characterize the effects of intravenous lidocaine on pain processing and cognitive function. A steady-state effect-site concentration of lidocaine will be achieved, and a short battery of cognitive behavioral tasks will be employed. At the dose target, pain task functional MRI and resting-state connectivity will be determined. This work will use a systems neuroscience approach to fill an important knowledge gap about the central effects of intravenous lidocaine, a commonly-used opioid alternative analgesic agent.

Aim1: Determine cognitive behavioral effects of a steady-state dose of IV lidocaine using a short battery of tasks. The investigators hypothesize that the administration of lidocaine will correlate to decreased pain ratings, slowed psychomotor response, and decreased memory encoding.

Aim2: Determine the neural effects of a steady-state dose of IV lidocaine in response to acute pain, and on resting connectivity. The investigators hypothesize that pain task-related activation will decrease in the insula and anterior cingulate, corresponding to decreased ratings of pain intensity and unpleasantness. Additionally, the investigators expect widespread decreases in long-range functional connectivity between brain areas know to be involved in these two areas and other known to be involved in pain processing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 70
  • Be of normal body-weight
  • Be generally healthy
  • Have none of the specific exclusion criteria
  • Have a valid email address and phone number throughout the study

Exclusion criteria

  • Pregnancy
  • Body mass index > 40
  • Having moderate to severe sleep apnea
  • Having chronic pain requiring the regular use of pain medicine 3 or more times per week
  • Having neurologic or psychiatric disease, including benign tremor, anxiety, and depression
  • Having a history of seizures
  • Having history of cardiac rhythm disturbance (such as heart block, or atrial fibrillation)
  • Being severely claustrophobic
  • Having metal implants or non-removable metal piercings
  • Having metal-containing tattoos, particularly on the face
  • Having a history of adverse reaction to lidocaine
  • Are regularly taking: antiepileptics, antidepressants, anti-psychotics, anti-anxiety medication, stimulants, sleep-aids, or pain medication
  • Are taking prescribed medications for psychiatric or neurological conditions
  • Having hypersensitivity to lidocaine or to any other local anesthetics of the amide type
  • Having Wolff-Parkinson-White syndrome
  • Having known renal or hepatic dysfunction
  • having glucose-6-phosphate dehydrogenase deficiency or history of methemoglobinemia

Treatment and study plan

Peripheral Nerve Stimulation

Device

Experimental acute pain stimulus will be delivered using an electric nerve stimulator.

Other names: Electric Nerve Stimulation

Lidocaine IV

Drug

Subjects will receive an intravenous infusion of lidocaine for about 30 minutes.

Other names: Xylocaine

Primary outcomes

  1. Brain Activation to Painful Stimulation Difference: Drug-free Condition Minus Lidocaine Condition

    Time frame: 4.5 minutes

    The Z-score is calculated by linear regression of the task timing against the MRI signal time-course (MRI data is in arbitrary units with no maximum or minimum) at each voxel (single data point in brain). Primary outcome is listed for the Right insula, but similar scores are calculated throughout the brain. Z-score of 0 indicates no task-related changes. Z-scores further from zero indicate stronger correlation between functional MRI signal change and the task timing, with positive values indicating increases in fMRI signal and negative Z-scores indicating decreases. Practically, higher positive Z-scores indicate increased brain activity and larger negative Z-scores indicate decreased brain activity. This outcome is reported as a number, as it is calculated using all the data across subjects combined into one statistical measure for the overall strength of difference in MRI signal change between two groups of data. Dispersion measures cannot be calculated for the summary Z-score.

  2. Resting-state Functional Connectivity Difference: Drug-free Minus Lidocaine

    Time frame: 8 minutes

    Functional connectivity (FC) measures the correlation of MRI signal time-series between brain regions. Changes in FC reflect differences in brain state, in this case between drug-free and lidocaine conditions. The reported value is the FC change between the right insula and anterior cingulate. A T-statistic of 0 indicates no change; more positive scores mean stronger connectivity in the drug-free condition, and more negative scores mean stronger connectivity with lidocaine. This outcome is a number reflecting the overall magnitude of difference between two datasets, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.

Secondary outcomes

  1. Pain Intensity Score Difference, Drug-free Condition Minus Lidocaine Condition

    Time frame: 12 minutes

    Numerical rating scale (0-10) pain score difference, comparing drug-free to the steady-state dose of lidocaine. Higher pain scores indicate more pain; a positive difference between pain score during the drug-free condition minus the value during the lidocaine condition indicates pain reduction (a better outcome).

  2. Memory Performance Difference, Drug-free Minus Lidocaine Condition

    Time frame: 3 minutes

    Performance on a short computer-based test of memory for visual pictures will be quantified using signal detection metric d-prime, reflecting ability (in standard deviation units) to detect previously-seen images from the background "noise" of previously un-seen images. Differences will be determined between the drug-free condition and the lidocaine condition. Higher values of d-prime indicate stronger memory performance; a positive difference for drug-free minus lidocaine condition would indicate the expected decrease in memory performance.

  3. Motor Response Time Differences

    Time frame: 1 minute

    Response times (in ms) after hearing a tone will be recorded and compared between the drug-free and Lidocaine condition, with the calculated difference in response times reported. Higher values will reflect slower responses, which are expected under the lidocaine condition.

Sponsors and collaborators

Lead sponsor

Keith M Vogt

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Acronym: NeuCLA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 15, 2022
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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